Paravertebral Calcitonin in Thoracotomy

Tanta University

Status: Active, not recruiting

Conditions: Thoracotomy; Calcitonin; Paravertebral

Treatments: Drug: bupivacaine-calcitonin-fentanyl; Drug: Bupivacaine-fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06330168

36264PR573/2/24

Details and patient eligibility

About

This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.

Full description

Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.

Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.

Using calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, investigators conducted this study based on the hypothesis that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.

In both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged ≥ 18 years
• American society of anesthesiology (ASA) physical status of I-III
• scheduled for elective thoracotomy

Exclusion criteria

• Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy.
• Pregnancy
• History of cardiovascular and gastro-esophageal surgery
• Preexisting pain syndrome or psychological disorders
• Severe hepatic, cardiovascular, or renal disorders
• Allergy to calcitonin
• Patients who will be re-operated and who will report infections

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups, including a placebo group

bupivacaine-calcitonin-fentanyl group

Experimental group

Description:

thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml)

Treatment:

Drug: bupivacaine-calcitonin-fentanyl

bupivacaine-fentanyl group

Placebo Comparator group

Description:

thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.

Treatment:

Drug: Bupivacaine-fentanyl